You are here

Research

FDA approves new Roche Ebola test for emergency use

WASHINGTON POST by  Rachel Feltman                      Dec. 29, 2014

Pharmaceutical company Roche announced Monday that the U.S. Food and Drug Administration had provided an Emergency Use Authorization -- a sort of pre-approval for use in particularly bad outbreaks -- for a new kind of Ebola test.

This isn't the first test to get this kind of approval during the 2014 outbreak of the Zaire strain of Ebola, which has killed more than 7,500 people to date and is still an ongoing crisis in parts of West Africa.... 

So it's no surprise that Swiss company Roche has put its version of a rapid test forward. The LightMix Ebola Zaire rRT-PCR Test works in about three hours, and is designed for Roche's testing consoles.

General Topic Tags: 
Problem, Solution, SitRep, or ?: 

Clinical trial for potential Ebola treatment started in MSF clinic in Guinea

MEDECINES SANS FRONTIERS                                     Dec. 26, 2014

A clinical trial for a possible treatment for Ebola started in Guinea on the 17th of December. The trial is led by the French medical research institute INSERM and is taking place at MSF’s Ebola Treatment Centre in Guéckédou, in the east of the country. Although every experimental treatment for Ebola patients offers hope, MSF remains prudent. There’s no guarantee that the drug will be effective and safe, and even if it is, it will not mean the end of the epidemic which continues to spread in the three most affected countries of West Africa.

The trial aims to include as many Ebola positive patients presenting at the MSF treatment centre in Guéckédou as possible. There will be no control group (group of patients who do not receive the treatment) in this study, as it is considered unethical to deny a group of patients the higher chance of survival that may come with the new treatment, especially given the high mortality of Ebola. Instead the outcomes of the patients will be measured against those of MSF patients admitted earlier this year, before the trial began. The first conclusive results are not expected before the first trimester of 2015....

Country / Region Tags: 
General Topic Tags: 
Problem, Solution, SitRep, or ?: 

Next in Ebola Plan: UN Teams to Study Lines of Transmission

REUTERS                                                              Dec. 24, 2014

ACCRA—Medical detective work will be the next big phase in the fight against Ebola when the United Nations deploys hundreds of health workers to identify chains of infection as the virus passes from person to person, top U.N. health workers said.
Health workers bury the body of a suspected Ebola victim at a cemetery in Freetown, Dec. 21, 2014.

The health teams will travel to each district and region of Guinea, Sierra Leone and Liberia, the three countries at the center of the epidemic, to trace who each infected person has potentially contacted.

The effort will run in parallel with measures to minimize the spread of infection, such as treating all Ebola patients in specialized centers and burying all victims safely.

But Phase Two of the plan is to contain the virus by understanding its lines of transmission, said World Health Organization Director-General Margaret Chan.

Read complete story

Problem, Solution, SitRep, or ?: 

Ebola raises profile of blood-based therapy

NATURE     by  Delcan Butler                                                                                        Dec. 23, 2014

With no drugs available to treat Ebola, eyes are turning to a therapy that had largely been relegated to the history books: transfusing patients with blood plasma donated by survivors, which contains antibodies against the virus.

Survivors of Ebola carry antibodies that might be used to save the lives of those infected with the virus. Michel du Cille/The Washington Post via Getty Images

Clinical trials of convalescent plasma therapy (CPT) have started in the past few weeks in Liberia, and are due to begin soon in Guinea and Sierra Leone. If the therapy saves lives, the approach could quickly be scaled up.

General Topic Tags: 
Problem, Solution, SitRep, or ?: 

Ebola vaccine 'promising in African populations'

BBC     By Smitha Mundasad                                Dec. 22, 2014
The first-ever trial of an Ebola vaccine in Africa shows promising initial results, according to a report in the Lancet medical journal.

Scientists say it is a crucial step as other vaccines have shown lower levels of protection in African populations.

Tests involving Ugandan and American volunteers reveal the vaccine is so far safe and generates an immune response in both populations.

It provides reassurance for other trials currently underway, they say.

No proven vaccine exists to prevent people from getting the disease, though several trials are underway.

Researchers from the National Institutes of Health tested this experimental vaccine on healthy adults in Uganda, having first trialled it in the United States.

Dr Julie Ledgerwood, the lead researcher, said: "This is the first study to show comparable safety and immune response of an experimental Ebola vaccine in an African population.

Read complete story

http://www.bbc.com/news/health-30577776

General Topic Tags: 
Problem, Solution, SitRep, or ?: 

Tekmira Inks Deal to Test New Ebola Drug in Humans

GENOMEWEB                                                                                                                        Dec. 22, 2014
NEW YORK -- Tekmira Pharmaceuticals announced today that it has signed a deal that will support the clinical testing of its experimental Ebola therapy designed against the strain of the virus behind the outbreak in West Africa.

Tekmira has long been developing an siRNA-based Ebola drug called TKM-Ebola, but a Phase I study of that agent was suspended by US regulators until the company could provide additional safety data. Earlier this year, Tekmira management indicated that that trial might not restart as early as anticipated since the firm had begun focusing on a version specifically for the Guinea strain of the Ebola virus, which is driving the ongoing outbreak.

Tekmira said it has now inked a manufacturing and clinical trial agreement with the University of Oxford to provide the new drug, called TKM-Ebola-Guinea, for clinical trials in West Africa. The university is the representative of the International Severe Acute Respiratory and Emerging Infection Consortium, which will be testing TKM-Ebola-Guinea in infected individuals with funding from the Wellcome Trust.

Country / Region Tags: 
General Topic Tags: 
Problem, Solution, SitRep, or ?: 

GSK Ebola vaccine trial seen moving to wider phase in February

REUTERS                                                                                              Dec. 19, 2014

Trials of GlaxoSmithKline's experimental Ebola vaccine are likely to move to a second phase in February, later than previously suggested, after a meeting of national regulators said they needed more information.

The World Health Organization, which hosted a meeting of national regulatory authorities and ethics committees earlier this week, said they had thoroughly discussed all aspects of the proposed trials at the two-day meeting.

"Reviewing countries requested additional documentation from the manufacturer of the vaccine, GlaxoSmithKline, before authorization of the trials," the WHO said in a statement.

Countries where the trials are planned -- Cameroon, Ghana, Mali, Nigeria and Senegal -- should receive and review the additional information by the end of January.

"If these steps are completed to the satisfaction of the national authorities, Phase II trials are likely to begin in February," the statement said.

The GSK vaccine is already undergoing Phase I trials, to check its safety in humans, in Switzerland, Britain, Mali and the United States, and is one of the two leading candidate vaccines for Ebola already undergoing tests.

General Topic Tags: 
Problem, Solution, SitRep, or ?: 

The Ebola Treatment You Haven't Heard Of

FORBES       by David Kroll                                                                                              Dec. 19, 2014

Pharmaceuticals and biotechnology-derived products have attracted the greatest public and professional interest in treating victims of Ebola virus disease. But a privately-held, small company with a treatment for shock and multi-organ failure may be the dark horse victor in the race to stop the West African outbreak. LB1148 from San Diego-based Leading BioSciences is starting Phase 2 clinical trials that build on 12 years of NIH-funded research to address an underappreciated, common denominator in shock and organ failure, including shock caused by Ebola infection.

Read complete story.

http://www.forbes.com/sites/davidkroll/2014/12/19/the-ebola-treatment-you-havent-heard-of/

Country / Region Tags: 
General Topic Tags: 
Problem, Solution, SitRep, or ?: 

One More Drug For Ebola Treatment Pipeline?

NBC NEWS by Maggie Fox                                                                                                      Dec. 19, 2014

German doctors think they have another possible drug to add to the Ebola treatment pipeline. It's one already shown to be safe and in trials to treat heart attack victims.

The drug, called FX06, is made using a natural human blood-clotting protein called fibrin. The hope is it can help reduce the leaking of blood vessels that can seriously threaten people with advanced Ebola infections.

The team at Frankfurt University Hospital say it may have helped save a Ugandan doctor they treated, although they note it failed to save a second patient.

Nonetheless, it should be tested, they wrote in the Lancet medical journal.

"Even though the patient was critically ill, we were able to support him long enough for his body to start antibody production and for the virus to be cleared by his body's defenses," said Dr. Timo Wolf, who helped lead the research team. "FX06 could potentially be a valuable agent in contribution to supportive therapy."

Read complete story.

Country / Region Tags: 
General Topic Tags: 
Problem, Solution, SitRep, or ?: 

Obama puts money on the table for Ebola vaccine developers

THE CANADIAN PRESS  by Helen Branswell                                                                     Dec. 19, 2014

TORONTO -- Earlier this week, U.S. President Barack Obama signed into law a little piece of legislation that may significantly change the economics of making drugs or vaccines to protect against Ebola and other viruses in its deadly family.

And it might at some point provide a tidy windfall for Merck, the company now developing an Ebola vaccine designed at Canada's National Microbiology Laboratory in Winnipeg.

A World Health Organization scientist unpacks the Canadian-made Ebola vaccine after receiving them in Geneva on Oct. 22, 2014. Swiss researchers temporarily halted a clinical trial of a Canadian-made Ebola vaccine after seeing an unexpected side-effect in a few people who received the serum. (Mathilde Missioneiro/THE CANADIAN PRESS/HO - WHO)

The bill -- S.2917, also known as "Adding Ebola to the FDA Priority Review Voucher Program Act" -- dangles a sizable carrot meant to entice pharmaceutical companies into developing vaccines and therapies to prevent or cure infection with the virus and other related pathogens in the filovirus family.

Country / Region Tags: 
Problem, Solution, SitRep, or ?: 

Pages

Subscribe to Research
howdy folks